510(k) · Cleared
ClearedAcucy® Influenza A&B Test with the Acucy® 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SEKISUI Diagnostics, LLC · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Apr 18, 2025 as substantially equivalent to K182001 (SEKISUI Diagnostics, LLC, 2018) after a 354-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Apr 18, 2025
- Review
- 354 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182001 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK182001 Acucy Influenza A&B Test with the Acucy SystemSEKISUI Diagnostics, LLC · 2018
- This deviceK241188 Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182001 | Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC | 2018 | — |
| 0 (this device) | K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182001 | Acucy Influenza A&B Test with the Acucy SystemSummary page 5…isory Panel: Microbiology (83) Prescription Use: Yes Predicate Device Assay: Acucy Influenza A&B Test with the Acucy System (K182001) Page 1 of 18 510(k) Summary… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Acucy Influenza A&B Test is a rapid chromatographic immunoassay for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from anterior nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use with the Acucy or Acucy 2 Reader as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection…
Read the full statement (228 words)
The Acucy Influenza A&B Test is a rapid chromatographic immunoassay for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from anterior nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use with the Acucy or Acucy 2 Reader as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2017-2018 influenza season when influenza A/H3N2 and A/H1N1pdm09 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241188: Acucy® Influenza A&B Test with the Acucy® 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241188
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026